JP2012516223A - Vascular access port and method related thereto - Google Patents

Abstract

The present invention provides a port for accessing a patient's blood vessel, the port having a passageway for directing a needle or other access device to be inserted directly into the blood vessel. The port can be implanted subcutaneously in the patient. Some ports are used for the formation or use of vascular access buttonholes.

Description

(References to federal-funded research or development)
This invention was made with grants from the US government under the National Institutes of Health SBIR Grant Nos. R43CA139608 and R44CA139608. The US government has certain rights in this invention.

  The present disclosure relates to subcutaneous vascular access ports and related systems and methods.

  The content of the disclosure described below is an example of embodiments of the present invention, and is not intended to limit the scope of the invention or to cover all. Certain of such exemplary embodiments shown in the figures are described.

1 is a perspective view of one embodiment of a vascular access port according to the present invention. FIG. It is a front view of this embodiment. It is a rear view of this embodiment. It is a top view of this embodiment. It is a bottom view of this embodiment. It is a right view of this embodiment, and a left view is a mirror image of a right view. FIG. 7 is a cross-sectional view of the vascular access port shown in FIG. 1 taken along line 7-7 of FIG. FIG. 2 is a perspective view of the vascular access port shown in FIG. 1 coupled to a blood vessel, partially cut away. FIG. 5 is a perspective view illustrating a stage of an exemplary method for implanting an embodiment of a vascular access port into a patient, with an incision made. FIG. 9B is a perspective view showing another stage of the method shown in FIG. 9A, showing a state where blood vessels are exposed. FIG. 9B is a perspective view illustrating another stage of the method shown in FIG. 9A, showing the attachment structure formed between the vascular access port and the blood vessel. FIG. 9B is a perspective view illustrating another stage of the method shown in FIG. 9A, showing additional attachment structures formed between the vascular access port and the blood vessel. It is a perspective view which shows the other step of the method shown to FIG. 9A, and shows a mode that the incision part was closed. FIG. 5 is a perspective view illustrating a stage of another exemplary method of implanting an embodiment of a vascular access port into a patient, with the patient's skin incised. FIG. 10B is a perspective view showing another stage of the method of FIG. 10A, showing a state in which the outer membrane of the blood vessel is separated. FIG. 10B is a perspective view showing another stage of the method of FIG. 10A, showing how an incision is formed in the outer membrane. FIG. 10B is a perspective view showing another step of the method of FIG. 10A, showing the formation of pockets in the outer membrane. FIG. 10B is a perspective view illustrating another stage of the method of FIG. 10A, depicting one embodiment of a vascular access port being inserted into a pocket. FIG. 10B is a perspective view illustrating another stage of the method of FIG. 10A, showing a vascular access port attached to a blood vessel. FIG. 10B is a perspective view showing another stage of the method of FIG. 10A, showing the incision in the patient's skin being closed. FIG. 6 is a cross-sectional view showing the palpation stage of the method of the present invention for the formation and use of a buttonhole access site for accessing the lumen of a blood vessel. FIG. 11B is a cross-sectional view illustrating another stage of the method of FIG. 11A, showing a pointed injection needle being inserted into the lumen of a blood vessel through one embodiment of a vascular access port. FIG. 11B is a cross-sectional view illustrating another stage of the method of FIG. 11A, representing a condition of compressing the patient's skin. FIG. 11B is a cross-sectional view illustrating another stage of the method of FIG. 11A, showing the insertion path and buttonhole access site formed. FIG. 11B is a cross-sectional view illustrating another stage of the method of FIG. 11A, showing a non-pointed injection needle being inserted into the lumen of the blood vessel through the insertion path, vascular access port, and buttonhole access site. FIG. 6 is a cross-sectional view illustrating a stage of another exemplary method of the present invention relating to the formation and use of a buttonhole access site for accessing the lumen of a blood vessel. FIG. 6 is a bottom view of a cut blood vessel having one embodiment of a buttonhole access site formed through one embodiment of a vascular access port of the present invention. It is a perspective view showing one embodiment of the vascular access system of the present invention which can be used for hemodialysis. It is a perspective view which shows other embodiment of the vascular access system of this invention which can be used for hemodialysis. FIG. 6 is a perspective view of another embodiment of the vascular access port of the present invention. It is a rear view of this embodiment. It is a front view of this embodiment. It is a top view of this embodiment. It is a bottom view of this embodiment. It is a right view of this embodiment, and a left view is a mirror image of a right view. It is sectional drawing of this embodiment. It is a perspective view which shows other embodiment of the vascular access port of this invention. It is a rear view of this embodiment. It is a front view of this embodiment. It is a top view of this embodiment. It is a bottom view of this embodiment. It is a right view of this embodiment, and a left view is a mirror image of a right view. It is sectional drawing of this embodiment. It is a perspective view which shows other embodiment of the vascular access port of this invention. It is a rear view of this embodiment. It is a front view of this embodiment. It is a top view of this embodiment. It is a bottom view of this embodiment. It is a right view of this embodiment, and a left view is a mirror image of a right view. It is sectional drawing of this embodiment. It is a perspective view which shows other embodiment of the vascular access port of this invention. It is a rear view of this embodiment. It is a front view of this embodiment. It is a top view of this embodiment. It is a bottom view of this embodiment. It is a right view of this embodiment, and a left view is a mirror image of a right view. It is sectional drawing of this embodiment. It is a perspective view which shows other embodiment of the vascular access port of this invention. It is a rear view of this embodiment. It is a front view of this embodiment. It is a top view of this embodiment. It is a bottom view of this embodiment. It is a right view of this embodiment, and a left view is a mirror image of a right view. It is sectional drawing of this embodiment. It is a perspective view which shows other embodiment of the vascular access port of this invention. It is a rear view of this embodiment. It is a front view of this embodiment. It is a top view of this embodiment. It is a bottom view of this embodiment. It is a right view of this embodiment, and a left view is a mirror image of a right view. It is sectional drawing of this embodiment. It is a perspective view which shows other embodiment of the vascular access port of this invention. It is a rear view of this embodiment. It is a front view of this embodiment. It is a top view of this embodiment. It is a bottom view of this embodiment. It is a right view of this embodiment, and a left view is a mirror image of a right view. It is sectional drawing of this embodiment. It is a perspective view which shows other embodiment of the vascular access port of this invention. It is a rear view of this embodiment. It is a front view of this embodiment. It is a top view of this embodiment. It is a bottom view of this embodiment. It is a right view of this embodiment, and a left view is a mirror image of a right view. It is sectional drawing of this embodiment. It is a perspective view which shows other embodiment of the vascular access port of this invention. It is a rear view of this embodiment. It is a front view of this embodiment. It is a top view of this embodiment. It is a bottom view of this embodiment. It is a right view of this embodiment, and a left view is a mirror image of a right view. It is sectional drawing of this embodiment. It is a perspective view which shows other embodiment of the vascular access port of this invention. It is a rear view of this embodiment. It is a front view of this embodiment. It is a top view of this embodiment. It is a bottom view of this embodiment. It is a right view of this embodiment, and a left view is a mirror image of a right view. It is sectional drawing of this embodiment. It is a perspective view which shows other embodiment of the vascular access port of this invention. It is a rear view of this embodiment. It is a front view of this embodiment. It is a top view of this embodiment. It is a bottom view of this embodiment. It is a right view of this embodiment, and a left view is a mirror image of a right view. It is sectional drawing of this embodiment. It is a perspective view which shows other embodiment of the vascular access port of this invention. It is a rear view of this embodiment. It is a front view of this embodiment. It is a top view of this embodiment. It is a bottom view of this embodiment. It is a right view of this embodiment, and a left view is a mirror image of a right view. It is sectional drawing of this embodiment. FIG. 6 is a perspective view of another embodiment of the vascular access port of the present invention. FIG. 27B is a perspective view of the vascular access port of FIG. 27A coupled to a blood vessel. It is a perspective view showing one embodiment of the vascular access system of the present invention. It is a perspective view which shows other embodiment of the vascular access port of this invention. It is sectional drawing which shows other embodiment of the vascular access port of this invention. It is a perspective view showing one embodiment of the vascular access system of the present invention which can be used for processing outside the blood.

  Certain embodiments of the vascular access port described herein may be implanted subcutaneously in a patient and used relatively long or indefinitely. The vascular access port can be implanted by any suitable method and, once implanted, is substantially fixed relative to the vessel wall. For example, in some implantation methods, the bottom surface of the vascular access port is placed in contact with the outer membrane of the blood vessel, and the port is defined by one or more sutures applied through at least a portion of all layers of the blood vessel. Fixed to the blood vessels. In a further embodiment of the present invention, a portion of the adventitia is detached or removed from the blood vessel so that the bottom surface of the port is relatively close to the medial layer of the blood vessel, and the port passes through the adventitia layer of the blood vessel and It is secured to the blood vessel by one or more sutures applied substantially completely through at least a portion of the media and intima layers. The surface of the port that contacts the vessel wall has an opening, and an access device such as a needle can be inserted into the lumen of the vessel. The vascular access port may be suitable for buttonhole cannulation techniques, where the buttonhole access site is formed in the vessel wall and / or used to access the vessel. The term “buttonhole” is used herein generally in the field of vascular access (eg in the field of hemodialysis), in particular in the context of cannulation technology, which term refers to an access device (injection) Can include a single insertion hole approximately the same size as the needle or other cannulation device), and the buttonhole facilitates insertion of the access device relative to other areas along the vessel wall be able to. Similarly, the port can be adapted to form and / or use a tube through the patient's skin and the buttonhole may be accessed repeatedly. In various embodiments relating to vascular access ports, systems using the ports, and methods of port implantation and use, these and other features and effects will become apparent from the disclosure herein.

  1-7 illustrate one embodiment of a vascular access port 100. FIG. The blood vessel access port 100 includes a base portion 102 and a main body portion 104. In the illustrated embodiment, the base portion 102 and the main body portion 104 are integrally formed as a single component, and the main body portion 104 extends from the base portion 102. The base portion 102 has an elongated shape in the vertical direction (longitudinal direction). In particular, the illustrated base 102 forms a substantially square outer perimeter 106 that is longer in the longitudinal direction than in the lateral direction (see, eg, FIG. 5). The edges and corners of the square outer periphery 106 can be rounded, thereby preventing damage to the outer periphery tissue when the vascular access port 100 is implanted.

  The base portion 102 has a base surface or bottom surface 108 that can face the blood vessel when the vascular access port 100 is coupled to the blood vessel. The bottom surface 108 can be configured to match the shape of the vessel wall. For example, the bottom surface 108 of the base portion 102 can be a laterally curved shape and have a radius of curvature substantially equal to the radius of curvature of the outer blood vessel surface to which the vascular access port is attached. The curved bottom surface 108 can define a cavity 110 (see FIGS. 2 and 3) and can receive at least a portion of the outer peripheral surface of the blood vessel. In the illustrated embodiment, the width and curvature of the bottom surface 108 are large enough to allow the cavity 110 to receive a substantial portion of the outer peripheral surface of the blood vessel. The above configuration allows stable contact of the bottom surface 108 with the blood vessel. Other suitable arrangements are possible as discussed below.

  The base portion 102 has one or more coupling flanges 112 and extends to at least a part of the outer peripheral portion of the base portion 102. In the illustrated embodiment, the first coupling flange 112 extends to the front end of the base portion 102 and the second coupling flange 112 is located at the rear end of the base portion 102. One or more attachment conduits or attachment passages 114 extend through the coupling flange 112. The attachment passage 114 can be configured to allow one or more strings or attachment members 116 to pass therethrough to attach the vascular access port 100 to a blood vessel, as will be discussed further below (eg, FIGS. 8, 9C, 10F). 11A and 12). Any suitable attachment member 116 can be used, for example, one or more of sutures, pinch rings, hooks or wires. However, in some embodiments of the present invention, the one or more attachment passages 114 may be suture holes. As discussed further below, in the illustrated embodiment, the base portion 102 includes a centrally located attachment passage 114 at each of its front and rear ends.

  The main body 104 can be positioned above the base 102. In the illustrated embodiment, the body portion is located upward along a central vertical longitudinal section 120 (see FIGS. 2 and 4) of the vascular access port 100. With respect to FIG. 4, the body 104 can be expanded outwardly from the central vertical longitudinal section 120 and can further be expanded rearward. Furthermore, as shown in FIGS. 3, 4, and 6, the vertex region 122 of the main body 104 can be disposed on the central vertical longitudinal section 120 and further approximately at the center in the vertical direction of the main body 104. For example, terms relating to the direction such as bottom, front, and back are used with respect to the orientation of the vascular access port 100 shown in FIG. This type of directional terminology does not limit the orientation of the vascular access port mounted in the patient. For example, in some embodiments of the present invention, when the vascular access port 100 is attached to a blood vessel, the front end of the vascular access port 100 is attached with the orientation upstream of the blood vessel relative to the rear end, and other implementations. In the configuration, the front end can be attached to the rear end in a direction downstream of the blood vessel.

  The guide passage 130 can extend through the body portion 140. In the illustrated embodiment, the guide passage 130 has a funnel portion 132 and a conduit portion 134. The funnel portion 132 defines a relatively large inlet 136 that extends or surrounds its proximal end or proximal opening, and further the funnel portion 132 narrows forward and downward from the inlet 136. In the illustrated embodiment, the forward end of the funnel portion 132 transitions to the conduit portion 134. The funnel portion 132 may include a base surface 138. The base surface 138 has a shape that protrudes rearward from the conduit portion 134 and expands rearward. As shown in FIG. 7, the base surface 138 of the funnel portion 132 can have an angle upward (and backward) relative to the bottom surface 108 of the base portion 102. The funnel portion 132 may further include a wing portion 140. Each wing portion 140 is curved upward and outward from the base surface 138, and is coupled to the support portion 142 at the front end thereof. As shown in FIGS. 4 and 5, the wing portion 140 extends outward beyond the outer peripheral portion 106 of the base portion 102, and the inlet 136 of the funnel portion 132 can be formed into a wide shape. The support 142 can rise upward from the upper surface of the conduit portion 134 and can have a substantially vertically oriented surface. The support portion 142 can extend to the conduit portion 134, at least a portion of which can be disposed directly above the conduit portion 134.

  The funnel portion 132 may completely surround the inlet edge of the conduit portion 134 and may further facilitate the tip of an access device 144 (see FIG. 11B), such as an injection needle, for example, entering the conduit portion 134. it can. The funnel 132 thus serves to enlarge the target area and can help guide the access device 144 to the desired portion of the blood vessel, as further described below. The funnel portion 132 is made of a material that can prevent or prevent the tip of the access device 144 from being embedded in the funnel portion 132 or removing a portion thereof, so that the tip of the access device is a conduit. Head to part 134. For example, in various embodiments of the present invention, the funnel 132 can be composed of titanium, stainless steel, hard plastic, or similar material.

  At least a portion of the inlet 136 of the funnel 132 can include a palpation protrusion 146, such as a palpation ridge. In the illustrated embodiment, the palpation protrusion 146 is substantially U-shaped and extends over the wing 140 and support 142 of the funnel 132, and the apex region 122 of the main body 104 further includes the palpation protrusion 146. It is located at the front end. The palpation protrusion 146 can be rolled to eliminate the pointed shape leading to tissue erosion. As described further below, the palpation protrusion 146 can be used to verify placement and / or orientation of the vascular access port 100 when the port 100 is implanted subcutaneously in the patient.

  The inlet 136 of the funnel 132 can be used to aid in hemostasis after the access device 144 is removed from the vascular access port 100. To this end, in some embodiments of the present invention, palpation protrusion 146 can form a substantially flat surface. As shown in FIG. 6, the palpation protrusion 146 of the illustrated embodiment is near or substantially flat with a flat surface and is not a completely flat surface due to slight longitudinal curvature. The palpation protrusion 146 also has a slight curvature in the lateral direction as seen in FIG. Moreover, in the illustrated embodiment, the rear edge of the inlet 136 smoothly transitions to the palpation protrusion 146 on one side thereof, slightly below the substantially flat surface defined by the palpation protrusion 146. It is in. Therefore, as described further below, the outer periphery of the inlet 136 of the implanted vascular access port 100 can be easily sealed by pressing the tissue surrounding the port 100 against the inlet 136 and compressing it.

  With reference to FIG. 7, the conduit portion 134 can extend through the base portion 102, and the lower end of the conduit portion 134 can define an opening 150 in the bottom surface 108 of the base portion 102. The opening 150 can be the distal opening 150 of the guide passage 130. The conduit portion 134 can inhibit movement of one or more access devices that are each inserted along a predetermined or repeatable path toward the opening 150. Thus, when the vascular access device 100 is secured to a blood vessel, the conduit portion 134 and the opening 150 can insert one or more access devices 144 into the same portion of the blood vessel. In one embodiment of the present invention, the conduit portion 134 defines a substantially constant inner diameter D along its length and inhibits movement of the access device 144 having an outer diameter that is slightly smaller than the inner diameter D. Can do. For example, in the illustrated embodiment, the conduit portion 134 is substantially cylindrical, and restrains the movement of a substantially cylindrical access device 144 (eg, a needle for a fistula bore) with an outer diameter slightly smaller than the inner diameter D. (See FIG. 11B). The inner diameter D and / or length of the conduit portion 134 can be set so that any access device 144 can be given the desired constraints.

  With continued reference to FIG. 7, the conduit portion 134 may define a central axis AX and an acute angle α with respect to the bottom surface 108. For example, in the illustrated embodiment, the vertical line along axis AX and bottom surface 108 forms angle α. In FIG. 7, the vertical line is indicated by a line L that defines the vertical length of the base portion 10. When the vascular access port 100 is coupled to a blood vessel, the longitudinal line L can be substantially parallel to the longitudinal axis of the lumen of the blood vessel (see FIG. 11A). Accordingly, in the illustrated embodiment, the conduit portion 134 can restrain movement of the access device 144 along a path that is not parallel to the vessel lumen and not orthogonal. In particular, the conduit portion 134 can restrain movement of the access device 144 along a passage that is just or approximately at an angle to the vessel lumen. In various embodiments, the angle α can be 15, 20, 25, 30, 35, 45, and 60 degrees or less, and 10, 15, 20, 25, 30, 35, 45, and 60 degrees. It can be set as the above value. The angle α can be a value in the range of about 30 degrees to about 60 degrees, can be about 15 degrees to about 45 degrees, or can be about 20 degrees to about 35 degrees. As described further below, the procedure for forming and using the buttonhole access site may require inserting an injection needle into the blood vessel at a specified acute angle. Thus, certain embodiments of the vascular access port 100 can be configured for use with this type of procedure, and the angle α can be selected according to the angle specified by the procedure.

  As described above, the inner diameter D defined in the conduit portion 134 can be greater than the diameter of the access device 144 inserted into the conduit portion 134. In some embodiments of the present invention, the conduit portion 134 is sufficiently larger than the access device 144 to allow the access device 144 to pass through the conduit portion 134 easily or with little resistance. By reducing or eliminating the force of inserting and removing the access device 144 from the conduit section 134, a stable attachment of the vascular access port 100 to the blood vessel after multiple steps of insertion and removal events. Can be maintained. Further, in the illustrated embodiment, the conduit portion 134 is open, unobstructed, transparent, unfixed, or empty. In other words, the conduit portion 134 does not have a closing device such as a diaphragm, a valve, or a plug stopper. The closure device can selectively open the conduit portion 134 before or during insertion of the access device 144, or during or after removal of the access device 144. Thus, the conduit part 134 can be selectively closed. As used herein, the term “closure device” is a mechanical, electromechanical, or other artificial, foreign or non-domestic device or system, manufactured outside the patient's body, and within the patient's body. To be planted. However, it does not include natural or patient-derived ones (eg, coagulated blood, tissue ingrowth, or vascular structures such as neointimal or temporary vessel walls) that may close the conduit 134 .

  In one embodiment of the invention, the shape of the conduit portion 134, or more generally the guide passage 130, does not change upon insertion of the access device 144 relative to the conduit portion 134 or removal of the access device 144. This is due, at least in part, to the absence of a closure device inside the conduit section 134 or the guide passage 130. More generally, the vascular access port 100 does not change upon insertion of the access device 144 or removal of the access device 144. In other words, in certain embodiments of the invention, one or more conduit portions 134, guide passages 130, as compared to one or more conduit portions 134, guide passages 130, and unchanged portions of the vascular access port 100, And a portion of the vascular access port 100 may not deform, rotate, translate, swivel, expand, contract, or otherwise move. No resistance to insertion or removal of the access device 144 caused by the closure device will therefore occur during use of the vascular access port 100. A method for hemostasis by the vascular access port 100 without using a closure device will be described below.

  Manufacture of embodiments of the vascular access port 100 can be facilitated by not having a closure device. For example, in the illustrated embodiment, the vascular access port 100 comprises a single component and / or a single material and no moving parts. Similarly, in the illustrated embodiment, the guide passage 130 is formed by one single component and / or one material and has no moving parts. Other or further embodiments of the invention may comprise a plurality of parts fixedly attached in a manner that is inseparable from each other. Embodiments of the vascular access port 100 can be manufactured by any suitable method such as machining, die casting, injection molding, etc., and comprise any biocompatible material such as titanium, stainless steel, hard plastic, etc. be able to. In some embodiments of the invention, the vascular access port 100 can comprise an absorbent material. For example, in various embodiments of the present invention, the vascular access port 100 is composed of ethylene oxide (e.g., pluronic) with caprolactone and glycolide (e.g., about 90% and 10% ratios of panacryl, respectively), [epsilon] -caprolactone, cellulose, propylene oxide. F-108), ethylene oxide with block polymers (eg dynagraft poloxamer), glycolide, dioxanone and trimethylene carbonate (eg biocins in proportions of about 60%, 14% and 26% respectively), glycolide and ε-caprolactone (Eg monoacrylic), hyaluronic acid esters (eg Hyaff), poly (butylene terephthalate) -co- (polyethylene glycol) (eg polyactive, osteoactive), polydioxanone (eg PDS), polyethylene oxide, polyg Lactin (eg bicyclyl, bicyclyl rapid, bicyclyl plus, polysorb), poly-glecapron (eg monocryl), polyglycolic acid (eg Dexon), polyglyconate (eg Maxon), polyglyceride (eg Trilucent), polylactic acid (eg For example, PLLA), poly L-lactic acid (PLLA) and poly glycolic acid (PGA) (eg, ratios of about 82% and 18%, respectively), poly-L-lactide, poly-D-lactide and polyglycolide, polyvinyl alcohol (Eg Bioinblue), polysaccharides, and one or more of propylene oxide.

  In other embodiments of the present invention, the vascular access port 100 can be composed of a composite material. For example, as described below, in some embodiments of the present invention, the guide passage 130 is constructed of a material that maintains hardness indefinitely or for a relatively long period of time, such as titanium, stainless steel, or first And other parts of the vascular access port 100 are constructed of an absorbent material, for example, a second type of absorption that is absorbed faster in the patient's body than the first type of absorbent material. Material.

  With reference to FIG. 5, the bottom surface 108 of the base portion 102 can include any suitable ingrowth-inducing cover 152 that facilitates tissue bonding or ingrowth to form or strengthen the bond between the vessel and the vascular access port 100. it can. In some embodiments of the present invention, the ingrowth-inducing cover includes a porous or textured structure and can be formed by any suitable method. For example, in some embodiments of the invention, the tissue is formed by compressing and sintering metal beads or powder (eg, titanium beads) on the bottom surface 108. In some embodiments of the invention, the beads can have a diameter of about 5 / 1000th of an inch (ie, approximately 0.13 mm) or smaller. In other or further embodiments of the present invention, the ingrowth-inducing cover 152 can be formed by machining, sandblasting, laser etching or injection molding of the bottom surface 108, or (eg, polyester, Dacron®). Can be formed by attaching a structure (such as e-PTFE) to the bottom surface 108.

  The ingrowth-inducing cover 152 can extend over the entire bottom surface 108 of the base portion 102 or can extend over a substantial portion of the bottom surface 108 as in the illustrated embodiment. In some embodiments of the present invention, the ingrowth-inducing cover 152 covers the area in front of the opening 150 and / or the area surrounding the opening 150, in which the blood vessel and the base 102 are securely attached. This may be desirable, and may help consistently and repeatedly guide the access device 144 into the same portion of the blood vessel as it is inserted into the opening 150. For example, the attachment region AR can be defined in view of providing a safe attachment to a blood vessel. The attachment region AR can be surrounded by a series of attachment passages 114, and one or more attachment devices 116 passing through the attachment passages 114 enter the lumen of the blood vessel through the side wall of the blood vessel, and connect the blood vessel access port 100 to the blood vessel. Can be combined. The attachment region AR is similarly covered by the ingrowth guidance cover 152 and can provide further bonding between the vascular access port 100 and the outer layer of the blood vessel (eg, the outer membrane or media). The adhesion area AR can surround the opening 150 as shown.

  In some embodiments of the present invention, the base portion 102 can be provided with an adhesive (not shown) in addition to or instead of the ingrowth-inducing cover 152 to secure the base portion 102 and the vessel. Allows adhesion. For example, in some embodiments of the present invention, the adhesive can include cyanoacrylate or fibrin glue.

  The vascular access port 100 is attached sufficiently securely to the blood vessel and remains fixed to the blood vessel when the port 100 is affected by forces from a needle or other access device 144. It is desirable. For example, the attachment device 116 coupled to the attachment passage 114, the tissue attached to the ingrowth guidance cover 152, and / or the bond that the adhesive has has the apex of the access device 144 forward along the funnel 132, or When pressed forward inside the conduit portion 134, it can resist relative longitudinal movement between the vascular access port 100 and the blood vessel. Similarly, this type of attachment function resists relative rotational movement between the vascular access port 100 and the blood vessel as the tip of the access device 144 pushes either of the wings 140 downward. can do.

  In some embodiments of the present invention, it is desirable to prevent, inhibit or prevent the body portion 104 from binding to peripheral tissue when the vascular access port 100 is implanted in a patient's body. As described above, it may be desirable to suppress the inner growth induction cover 152 with respect to the bottom surface 108 of the base portion 102. For example, the blood vessel can move somewhat relative to the outer tissue, but the vascular access port 100 can remain fixed relative to the blood vessel rather than to the tissue surrounding the blood vessel. Is even more desirable. Thus, in some embodiments of the present invention, the body portion 104 is relatively smooth. In other embodiments of the present invention, at least a portion of the body portion 104 may include an ingrowth induction cover 152.

  In some embodiments of the present invention, at least a portion of the vascular access port 100 can have a cover (not shown) (such as a covering and / or an embedded portion), such as the covering and Can have a cover (not shown) (such as an embedding material), which can be preservatives, antibacterials, antibiotics, antivirals, antifungals, antiinfectives, or other desirable properties (eg, ports One or more materials or chemicals that provide the ability to inhibit, reduce or stop the growth of microorganisms at or near the surface. For example, in various embodiments, the vascular access port 100 comprises silver, platinum, gold, zinc, iodine, phosphorus, bismuth, alexidine, 5-fluorouracil, chlorhexidine, sulfadiazine, benzalkonium chloride, heparin, complex heparin. Benzalkonium chloride, 2,3 dimercaptopropanol, ciprofloxacin, cosmocil, cyclodextrin, dicloxacillin, EDTA, EGTA, myeloperoxidase, eosinophil peroxidase, fusidic acid, hexyl bromide, triclosan, Polymyxin B, isopropanol, minocycline rifampin, minocycline EDTA, octenidine, orthophenylphenol, triclocarban, triclosan, cefazoline, clindamycin, dicloxacillin, fusidic acid, o Sashirin may include Rifanbin, antibodies, peptides, polypeptides, one or more free fatty acids and oxidative enzymes. In some embodiments of the present invention, the covering and / or the embedded material can be separate from the ingrowth-inducing cover 152 or can have an independent shape (eg, not coextensive). For example, in some embodiments of the present invention, an antimicrobial cover is constrained against the body portion 104 of the vascular access port 100 while an ingrowth-inducing cover 152 against the base portion 102 of the vascular access port 100. Is bound.

  In the illustrated embodiment, the front surface 156 of the main body portion 104 rises smoothly from the base portion 102 and tilts backward. As shown in FIG. 7, in some embodiments of the present invention, the front surface 156 can be substantially parallel to the conduit portion 134, usually according to the shape of the conduit portion 134. For example, the front surface 156 can have a convex roundness similar to the conduit portion 134. The body 104 can smoothly transition from the front surface 156 to the recess 158 on both sides thereof, thereby making it possible to relatively reduce the surface area of the body that may adhere to the tissue. The recess 158 can further contribute to a reduction in material costs associated with the manufacture of the vascular access port 100.

  Various parameters of the vascular access port 100 can be adjusted or selected to obtain the desired performance. For example, with reference to FIG. 3, the maximum width WF of the funnel portion 132 can be greater than the maximum width WB of the base portion 102. This type of arrangement can be suitable when the vascular access port 100 is configured for coupling to a relatively small blood vessel or when a relatively large target area is desired. In various embodiments of the present invention, the width WF is greater than or equal to 1.0, 1.25, 1.50, 1.75, or 2.0 times the width WB.

  In some embodiments of the present invention, the width WB of the base portion 102 may be equal to or smaller than the width of the blood vessel, and the blood vessel access port 100 is attached. In various embodiments of the present invention, the width WB of the base portion 102 can be about 6,7,8,9,10,11 or 12 mm or more, or about 6,7,8,9,10, It can be 11 or 12 mm or less.

  In some embodiments of the present invention, the height H of the vascular access port 100 may be adjusted or selected according to the depth at which the port 100 is implanted in the patient's body. For example, some embodiments of vascular access port 100 may be suitable for use with shallow blood vessels (eg, veins with forearm arteriovenous fistulas), while in other embodiments, deep blood vessels ( For example, it may be suitable for use on the upper arm (ulcer side skin vein). The depth at which the port 100 is placed below the patient's skin surface can further vary due to differences in anatomy between individual patients. The sites in which various embodiments of the vascular access port 100 can be implanted include the head, the ulcer, the femur, the throat, the subclavian, or other suitable veins, arteries, and canal , Stomach, and other organs, and more generally any suitable structure that surrounds or encloses the region with walled membrane tissue.

  In some embodiments of the present invention, located under the patient's skin to a degree sufficient to prevent tissue erosion, but it is difficult to palpate the vascular access port 100 or there is sufficient information regarding the location or orientation of the port. It is desirable for the implanted vascular access port 100 not to be so deep that it cannot be obtained. In various embodiments of the present invention, the minimum distance between the patient's skin surface and the implanted port is about 3, 4, 5 or 6 mm or less, about 3, 4, 5 or 6 mm or more, or about 3, 4,5 or 6 mm or less.

The height H is defined as the minimum distance between the apex region 122 and the bottom surface 108 of the base 102, and the height H is selected, adjusted, or otherwise set to a desired level below the patient's skin surface. The vascular access port 100 can be placed at a depth. In various embodiments of the present invention, the height H is about 2,3,4,5,6,7,8,9,10,11,12,13,14 or 15 mm or less, or about 2,3,4. , 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 mm or more. In other or further embodiments of the present invention, the height H is no more than 0.5,0.75,1.0,1.5,2.0,2.5,3.0 or 3.5 times the width WB of the base portion 102, or 0.5,0.75,1.0,1.5,2.0. , 2.5, 3.0 or 3.5 times or more. In other or further embodiments of the invention, the angle α defined above can vary with the height H. For example, in some embodiments of the invention, the angle α increases with increasing height H.

  Of course, various features of the embodiments of the vascular access port 100 described above can be altered or modified. In some embodiments of the present invention, for example, the base portion 102 and the body portion 104 can be comprised of separate parts that can be coupled together. For example, the base portion 102 can include a relatively flexible material that can easily change shape to conform to the surface of a blood vessel, while at least a portion of the body portion 104 (eg, funnel portion 132). ) Can include relatively hard materials. In other or further embodiments of the present invention, the cavity 110 defined by the base portion 102 can be sized and receive any portion of the outer periphery of the vessel therein. As further described below, the guide passage 130 can be of different sizes and configurations.

  Vascular access port 100 can be implanted in a patient and used in any suitable manner. As described above, the bottom opening 150 defined by the guide passage 130 is secured to the blood vessel so that the guide passage 130 and / or the opening 150 repeatedly guides the access device to the same location on the blood vessel. As can be done, it may be desirable to secure the vascular access port 100 to a blood vessel.

  FIG. 8 shows an example of this type of arrangement. The vascular access port 100 is fixed securely and directly to the blood vessel 200. The blood vessel includes three layers, an outer membrane layer 202, a middle membrane layer 204, and an inner membrane layer 206. With respect to securing or attaching the vascular access port 100 to the blood vessel 200, the term “direct” as used herein is fixedly attached to some portion of the vascular access port 100 that abuts the blood vessel 200. Means that. In the illustrated implementation expectation, the attachment device 116 includes a continuous suture that extends through the attachment passage 114 of each vascular access port 100. One or more suture loops extend through all three layers 202, 204, 206 of the blood vessel 200.

  In certain embodiments of the invention, one or more attachment devices 116 extend through more layers of blood vessel 200 than just the outer membrane layer 202 (or a portion thereof), or in certain cases, the media It may be desirable to pass through layer 204 and / or inner membrane layer 206. For example, it can be seen that the ports move relative to the medial layer 204 and the intimal layer 206 as a result of attaching a particular port only to the outer membrane layer 202 (ie, not attached to other tissues). ing. During actions such as palpation of the port or various daily activities during the cannulation procedure, the port can move longitudinally and / or laterally relative to the inner layers 204, 206 of the blood vessel 200. . This type of mobility of the vascular access port potentially creates multiple puncture sites for the vessel in the course of repeated cannulation, potentially weakening the vessel wall over time and potentially May result in aneurysm, vascular stenosis, hematoma and / or bleeding.

  FIGS. 9A-9E represent various stages in an example method for implanting a vascular access port 100 in a patient 210, allowing the vascular access port 100 to have direct access to the blood vessels of the patient 210. FIG. The term “patient” is used broadly herein and includes any experimental animal that can undergo or be subjected to several procedures or treatments, whether given by others or given by themselves. The term is not limited to individuals within a health facility. The vascular access port 100 can be used for any suitable blood vessel, such as an artery 212, a vein 214 (both shown in FIG. 9A), or an artificial graft (see FIG. 14B). As described above, the blood vessel may be in any part of the patient 210's body (eg, neck, upper arm, forearm or leg), and the blood vessel is relatively deep or shallow relative to the patient's skin 216. Can be located. Many uses of the implanted port 100 are applicable, such as hemodialysis, chemotherapy, antibiotic treatment, complete parenteral nutrition, pain management, aquapheresis, blood exchange, hydration or any suitable Including various types of long-term treatment. In the illustrated method, the vascular access port 100 is shown implanted in the forearm of a patient 210, and in particular, the vascular access port 100 is shown connected to a vein 214 with an arteriovenous fistula 218 for hemodialysis. Note that the vein 214 is a blood vessel having three layers, such as the blood vessel 200 shown in FIG. 8, and is therefore referred to below as the blood vessel 200 to illustrate the more general applicability of the procedure described. .

  With reference to FIG. 9A, an incision 220 is formed in the skin 216 of the patient 210. In the illustrated embodiment, the incision 220 can be about 4-5 cm long. The incision 220 extends substantially parallel to the blood vessel 200, but can be offset relative to it (ie, not directly above the blood vessel 200). In the illustrated embodiment, the incision 220 is offset about 2-3 cm from a position directly above the blood vessel 200. With further reference to FIG. 9E, this type of orientation of the incision 220 can facilitate access to the vascular access port 100 after the implantation procedure is complete. In other methods, the incision 220 can be located directly above the blood vessel 200 and / or can be angled or completely transverse to it. The incision 220 may be formed by the operator 224 using any suitable technique and instrument.

  With reference to FIG. 9B, the blood vessel 200 can be exposed at the incision 220 by removing, partially removing, or separating the skin, fat, fascial layer from the outer membrane layer 202 of the blood vessel 200. By any suitable method (eg, use of tissue spreader 230), exposure of blood vessel 200 can be maintained.

  With reference to FIG. 9C, the initial attachment of the vascular access port 100 to the blood vessel 200 can be made at the front or back end of the vascular access port 100. In some procedures, the attachment device 116 passes through all three layers 202, 204, 206 (see FIG. 8) of the blood vessel 200 and further through the attachment passage 114 to either the front end or the rear end of the blood vessel access port 100, respectively. Prior to use of the mounting passage, it can be inserted along the lateral center of the port 100. Initial attachment of the front and / or rear end of the vascular access port 100 allows the vascular access port 100 to be attached and maintained in a desired orientation during the implantation procedure.

  As described above, any suitable attachment device 116 can be used in securing the vascular access port 100 to the blood vessel 200. The attachment device 116 can include, for example, one or more of sutures, pinch rings, hooks or wires. Once the mounting device 116 is in the desired position, it can be securely tied, crimped, twisted, or otherwise secured.

  In the illustrated embodiment, the attachment device 116 can include a continuous suture and a loop can be created through the plurality of attachment passages 114. In the illustrated embodiment, a single continuous suture 116 is used to secure the vascular access port 100 to the blood vessel 200. In other embodiments of the invention, the suture 116 extends through a smaller number of attachment passages 114, and one or more additional sutures 116 can be used. For example, as described above, in some embodiments, a separate suture 116 secures each end of the vascular access port 100 prior to attaching the suture to any of the remaining attachment passages 114.

  Various options are possible for securing one or more sutures 116 in place. For example, in some procedures, the suture needle 232 can be inserted through the wall of the blood vessel 200 at a location close to the attachment passage 114 and can pass through the attachment passage 114 after passing through the vessel wall. it can. The suture 116 associated with the suture needle 232 can then be tied using a surgical knot and excess suture can be cut off. In other procedures, the suture 116 can be placed at a desired location within the wall of the blood vessel 200 with at least one leg protruding from the adventitia layer 202. The protruding leg of the suture 116 can be received through the desired attachment passage 114 of the vascular access port 100 to bring the port 100 into contact with the blood vessel 200. The suture 116 can then be tied and cut off. Any method can be used to secure the suture 116 through the desired number of attachment passageways 114 of the vascular access port 100. Any other stitching or attachment technique can be used. In some embodiments of the present invention, only some effective attachment passages 114 are used.

  With reference to FIG. 9D, the vascular access port 100 can be secured to the blood vessel 200 through any or all remaining attachment passages 114 using additional sutures 116 as required. In some embodiments of the invention, the attachment passageway 114 is blocked (eg, with silicon) to prevent tissue ingrowth. In other embodiments, the attachment channel 114 may remain open and allow tissue ingrowth in or through it.

  With reference to FIG. 9E, the site of the incision 220 is closed by any suitable method (eg, one or more sutures 234). As described above, the incision 220 can be offset from a position directly above the vascular access port 100. In this type of arrangement, the access device 144 can be inserted through the skin 216 and into the vascular access port 100, via a surface insertion site 236 that hardly interacts with the site of the incision 220, or in particular the skin. No contact with some or much scar tissue at or below the 216 surface. In certain cases, as will be described further below, this can assist in forming an insertion path that extends from the surface insertion site 236 to the vascular access port 100.

  In certain embodiments of the invention, it may be desirable to wait for a period of days or weeks after implantation of the vascular access port 100 and thereby before accessing the blood vessel 200. The waiting period can provide sufficient time for tissue ingrowth in appropriate areas of the vascular access port 100, thereby providing a more secure connection between the vascular access port 100 and the blood vessel 200.

  FIGS. 10A-10G illustrate various stages of another exemplary method of implanting a vascular access port 100 in a patient 210 that allows direct access to the blood vessel 200 of the patient 210. FIG. Although the methods shown in FIGS. 9A-9E and 10A-10G are represented as similar sites within the patient 210, it is understood that the methods are applicable at other sites.

  With reference to FIG. 10A, the incision 220 can be formed in the skin 216 of the patient 210, and in some embodiments of the invention can have a length of about 4 cm to 5 cm. The incision 220 can extend substantially parallel to the blood vessel 200 and can extend with an offset relative to the blood vessel 200. In some embodiments of the invention, the offset distance can be from about 2 cm to about 3 cm.

  With reference to FIG. 10B, blood vessel 200 can be exposed at the incision 220 by removing, partially removing, or separating skin, fat, fascial layers from the outer membrane layer 202 of blood vessel 200. By any suitable method (eg, use of tissue spreader 230), exposure of blood vessel 200 can be maintained.

  With reference to FIG. 10C, a portion of outer membrane 202 is isolated or separated from other portions of blood vessel 200 by any suitable method (eg, by one or more forceps 242). Each set of forceps 242 can be used to grasp or bundle a portion of the outer membrane 202 and / or fascia layer or fat that has not been removed or separated and deployed by the tissue spreader 230.

  With respect to FIG. 10C, while a portion of the outer membrane 202 is held open, a small incision 244 is formed therein by any suitable method (eg, by a scalpel or scissors 246).

  With reference to FIG. 10D, hemostatic forceps 240 can be inserted through incision 244 to slide between the separated outer membrane 202 and the remaining layers of blood vessel 200. In this example, it may be difficult to separate all of the outer membrane 202 from the media layer 204 of the blood vessel 200. In the illustrated embodiment, the media layer 204 is shown but is covered by a thin layer of the outer membrane 202. The hemostatic forceps 240 can be used to expand the pocket 248 directly in the outer membrane 202 layer. Although not shown, in some cases, forceps 242 may be used to maintain the state of outer membrane 202 during formation of pocket 248.

  In certain embodiments of the present invention, the pocket 248 can be large enough to receive the vascular access port 100 therein, while in other cases the pocket 248 is slightly smaller than the vascular access port 100. It may be smaller. In some embodiments of the invention, the pocket 248 can have a length of about 2.0, 2.5, 3.0, or 3.5 cm or less, and no more than 70, 80, or 90% of the outer diameter of the media layer 204. Can have a width.

  With reference to FIG. 10E, the vascular access port 100 can be inserted into the pocket 248 through the incision 244. In some cases, forceps 242 or other clamping device is used to maintain the shape of outer membrane 202 during insertion of vascular access port 100. The vascular access port 100 can be inserted into the pocket 248 with the posterior end first or the anterior end first as shown, and the port 100 can be opposite the incision 244. It can be pressed against the end of the pocket 248.

  With reference to FIG. 10F, the outer membrane 202 can cover all or substantially all of the vascular access port 100 when the implanted vascular access port 100 is placed in the pocket 248. The suture 116 passes through the attachment passage 114 and further through the rest of the outer membrane layer 202, just as it passes through the medial and intimal layers 204, 206 to attach the vascular access port 100 to the blood vessel 200. You can proceed through the parts of A suture knot can thus be formed outside the outer membrane 202. In other embodiments of the invention, the suture 116 may not be passed through the separated portion of the outer membrane 202 and may be tied before being covered by the outer membrane 202.

  FIG. 10G represents the position of the incision 220 in the closed configuration. The incision 220 can be closed by any suitable method (eg, by any of the methods described above with respect to FIG. 9E).

  Referring again to FIGS. 10C-10F, in other methods, at least a portion of the outer membrane 202 can be removed rather than forming a pocket 248 therein. The vascular access port 100 can be placed on top of a thin layer of the outer membrane 202 where at least a portion of the outer membrane 202 has been removed, and the suture 116 passes through the attachment channel 114 to make the outer skin thinner. It can be inserted directly through the membrane layer 202, the middle membrane layer 204 and the inner membrane layer 206. When implanted by this method, the vascular access port 100 may be at least initially not stable with respect to the blood vessel 200 (rather than when it is inserted into the pocket 248).

  FIGS. 11A-11E represent various procedures that can be performed in connection with the implanted vascular access port 100. As will be described later, the vascular access port 100 can facilitate the creation of a buttonhole. Once it is formed, the vascular access port 100 can further facilitate the use of a buttonhole. These and / or other vascular access port 100 effects will become apparent from the disclosure below.

  Further, as described above, tissue can grow or be combined into various regions of the vascular access port 100. For example, vascular tissue can grow into an ingrowth induction cover 152. In some embodiments of the present invention (not shown in FIGS. 11A-11E), the skin tissue can grow and become at least part of the guide passage 130.

  FIG. 11A represents one embodiment of vascular access port 100, which is implanted in patient 210 in any suitable manner (eg, by the method shown in FIGS. 9A-9E). The opening 150 of the guide passage 130 is at or adjacent to the blood vessel 200. In particular, in the illustrated embodiment, the opening 150 is formed in the outer membrane layer 202 of the blood vessel 200.

  At the illustrated stage, the clinician 260 palpates the skin 216 to locate the vascular access port 100 and determine the orientation. The term “clinician” is used broadly herein and includes any individual who performs a treatment or procedure on an implanted vascular access port. The term is not limited to individuals within a medical facility, regardless of whether the individual is a person (eg, a patient) or someone else who is implanted with an access port. In the illustrated embodiment, the clinician 260 is fingering the skin 216 located above the apex region 122 of the palpation protrusion 146. In other examples, the clinician 260 can palpate any other suitable portion of the body 104 to determine the location (eg, depth) and orientation of the port 100. For example, the clinician 260 can use one or more fingers and / or thumbs to touch the skin 216 on or near other parts of the palpation protrusion 146, or any of the wings 140 Squeeze the skin 216 on the side of the skin. In other or further embodiments of the present invention, the clinician can visually determine the location and orientation of the port 100. Before or after the step shown in FIG. 11A, the clinician 260 can clean the surface of the skin with any suitable disinfectant to reduce the risk of pathogens entering the patient's bloodstream.

  FIG. 11B represents one embodiment of an access device 144 that first directly accesses the lumen 262 of the blood vessel 200 through the vascular access port 100. Although the clinician 260 finger is not shown in FIG. 11B, the clinician 260 can continue palpating the vascular access port 100 while the access device 144 is inserted into the skin and vascular access port 100. The guide passage 130 can facilitate achieving the desired placement of the access device 144. The clinician 260 can also fine tune its orientation by applying pressure to the vascular access port 100.

  Access device 144 can include any suitable device, between the outer location of skin 216 and vascular lumen 262 when the device is plugged into lumen 262 via vascular access port 100. A structure for fluid communication is provided. For example, in various embodiments of the present invention, the access device 144 can include a needle or a catheter. In many embodiments of the present invention, the access device 144 can be relatively stiff because it can easily pass through the skin 216. Thus, in some embodiments of the present invention, the catheter can be an over-the-needle catheter.

  Standard needles currently used in hemodialysis or other procedures can be used with embodiments of the vascular access port 100, which can facilitate the use of this type of port. For example, standard procedures for forming and using buttonholes in blood vessels by well-known freehand methods can be easily adapted to “device assisted” buttonhole technology using vascular access port 100, and This can be done without changing the equipment required in existing procedures.

  The procedure stage shown in FIG. 11B represents the first access of the lumen 262 of the blood vessel, and the access device 144 is represented as a sharp point and passes through the intact skin to form the insertion path 264. And also allows the access device 144 to be more easily inserted through the insertion site 266 of the blood vessel 200. As will be described further below, however, other embodiments of the access device 144 that are not pointed after multiple access events can be used. For example, as described below, the sharp access device 144 is used in many access events (eg, 6, 7, 8, 9 or 10 access events) until the insertion path is formed in the patient's skin. The access device 144 with a pointed tip can then be used.

  In certain embodiments of the invention, the access device 144 can include a 14 gauge to 20 gauge sized needle. As described above, the diameter and length of the conduit portion 134 can be configured to guide the access device 144 to a particular region of the blood vessel 200. This can be achieved by a relatively close fit between the vascular access port 100 and the conduit section 134. At a location where the access device 144 exits the conduit portion 134 through the opening 150, it can be oriented in a predetermined direction. In some cases, it may be desirable for the conduit portion 134 to be sized such that there is at least a small space between its inner wall and the access device 144 when the access device 144 is inserted therein. This can prevent or reduce coupling of the access device 144 within the conduit portion 134 that is more likely to occur when tissue grows into at least a portion of the conduit portion 134. In some embodiments of the present invention, the space between the conduit section 134 and the access device 144 can be averaged or optimized so that a sufficiently close fit is obtained and the vascular access device 144 is When the vascular access device 144 is repeatedly guided to substantially the same place in the blood vessel 200 and inserted into the blood vessel 200, hemostasis is performed, and the access device 144 is prevented from being coupled in the conduit portion 134, and the occurrence thereof is prevented. It can be reduced or suppressed. In various embodiments of the present invention, the inner diameter of the conduit section 134 is larger than the outer diameter of the access device 144, in the range of about 0.25 gauge to about 3.0 gauge, about 0.5 gauge to about 2.0 gauge, about 0.75 gauge to 1.5 gauge. Gauge, used in the range of about 0.75 gauge to about 1.25 gauge, about 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, or 3.0 gauge or more, or about 0.25, 0.5, 0.75, 1.0 , 1.25, 1.5, 1.75, 2.0, 2.5, or 3.0 gauge or less. In some embodiments of the present invention, the conduit portion 134 is approximately 1 gauge larger than the access device 144 that it is configured to be used with. For example, in the illustrated embodiment, the conduit portion 134 can be sized to approximately 14 gauge, and the access device 144 can include a 15 gauge fistula needle.

  Still other configurations for the conduit portion 134 and the access device 144 are possible. For example, the one or more conduit portions 134 and the access device 144 can have other shapes that are not cylindrical. In certain such embodiments, the shape of the conduit portion 134 and the shape of the access device 144 can be complementary to each other, while in other embodiments, the cross-sectional shape of the conduit portion 134 is that of the access device 144. It may be different from the cross-sectional shape.

  As mentioned above, some procedures for the formation and use of buttonhole cannulation sites can require the insertion of a needle into a blood vessel at a specified acute angle. In some embodiments of the present invention, the angle α (see FIG. 7) defined in the conduit section 134 can be adapted to this particular angle, and the conduit section 134 can be connected to the blood vessel 200 by the access device 144. The vascular access port 100 can be constrained to be plugged at an angle α and the vascular access port 100 is configured for use in this type of method.

  FIG. 11C shows the stage of treatment after the access device 144 is removed. The insertion site 266 is shown closed and it can heal. Before the insertion site 266 closes or heals, however, blood 268 can exit from it, further filling the guide passage 130 and the insertion passage 264. The practitioner 260 can squeeze the top of the vascular access port 100 until the bleeding stops on the surface of the skin 216 to close the insertion path 264. For example, the pad 269 (eg, gauze) can be simultaneously placed on the upper end of the insertion path 264 and the expert 260 can press. As described above, the inlet 136 of the guide passage 130 can be configured to facilitate hemostasis. For example, the inlet 136 can be relatively flat, and by compressing the top of the inlet 136, tissue around the outer periphery of the guide passage 130 can effectively seal the guide passage 130 at the inlet 136. . In some embodiments of the present invention, the insertion path 264 can be closed by squeezing tissue located above the guide passage 130 using a two-finger technique. In some embodiments of the present invention, compression can be performed in about 5 minutes, 6, 7, 8, 9, or 10 minutes or less for hemostasis.

  A relatively intimate attachment between the vascular access port 100 and the blood vessel 200 helps to achieve hemostasis (eg, as provided by tissue ingrowth within the attachment region AR (see FIG. 5)). For example, tissue ingrowth around the opening 150 can inhibit or prevent blood 268 from leaking outward between the base 102 of the vascular access port 100 and the blood vessel 200.

  The procedure described with respect to FIGS. 11A-11C can be repeated multiple times. For example, referring again to FIG. 11B, the pointed second access device 144 can be inserted through the insertion path 264 and into the vascular access port 100 as a second insertion. However, as a result of palpation of the vascular access port 100 between the first and second access events and / or during the second access event, the vascular access port 100 and the blood vessel 200 to which it is attached are inserted. As a result, the conduit section 134 can no longer be aligned with the insertion path 264. As the access device 144 passes through the insertion path 264, the tip of the access device 144 can contact the funnel portion 132. As the access device 144 advances further through the insertion path 264, the funnel portion 132 can guide the tip of the access device 144 into the conduit portion 134. In some cases, guidance of the tip of such an access device 144 associated with the vascular access port 100 can align the insertion path 264 and the conduit portion 134 with each other. Once the tip of the access device 144 enters the conduit portion 134, the conduit portion 134 directs the tip of the access device 144 to the insertion site 266 of the blood vessel 200. The vascular access port 100 can therefore guide the access device 144 to the same insertion site 266 where the vascular lumen 262 was accessed in the first access event.

  FIG. 11D represents insertion path 264 and insertion site 266 after multiple access events. As shown, the insertion path 264 can become clearer over time, which can be due, for example, to the formation of scar tissue or connective tissue. Similarly, the insertion site 266 can become clearer over time so that it is easier to insert the access device 144 therethrough. This type of insertion site 266 that passes through the vessel wall may be referred to as a buttonhole access site, or more generally a buttonhole. Accordingly, the insertion site 266 may also be referred to herein as a buttonhole 266. In some embodiments of the invention, a clear insertion path 264 and / or buttonhole 266 may be formed after 6, 7, 8, 9 or 10 access events.

  In other embodiments of the invention, the insertion path 264 and buttonhole 266 can be formed by insertion of an over-the-needle catheter (not shown) that passes through the vascular access port 100. The needle portion can be removed and the catheter portion can be kept in place until the insertion path 264 is clearly formed. The catheter can then be removed.

  As described above, the vascular access port 100 and the blood vessel 200 may move relative to the insertion path 264 between access events. However, in certain embodiments of the present invention, the funnel portion 132 of the guide passage 130 is sufficiently large so that the end of the insertion path 264 leads to at least a portion of the funnel portion 132 regardless of any such movement. Or extend through at least a portion of the funnel portion 132. Thus, the vascular access port 100 can act as a movable extension of the insertion path 264, which causes the access device 144 to be buttonholed regardless of any relative movement between the insertion path 264 and the blood vessel 200. Configured to be consistently guided to 266. In some embodiments of the present invention, however, relatively little movement may occur between the insertion path 264 and the vascular access port 100, and the access device 144 is inserted through the insertion path 264. , It is possible to enter the conduit portion 134 directly without contacting the funnel portion 132.

  FIG. 11D further illustrates that a scab 270 can be formed over the insertion path 264 during an access event. The crust 270 can be removed prior to the access event. In other embodiments of the present invention, an artificial cover can be formed over or instead of the scab 270.

  FIG. 11E depicts the use of the non-tip access device 144 after proper formation of the insertion path 264 and buttonhole 266. FIG. Since the tip of the access device 144 is not sharp, the device 144 can be guided through the insertion path 264 and the buttonhole 266 in a manner that is less damaging and more comfortable for the patient. Using a non-tip access device 144 can further reduce the risk of penetrating the opposite side of the blood vessel 200.

  As described above, an over-the-needle catheter can be used with the vascular access port 100 in some embodiments of the present invention. In certain procedures, the needle / catheter assembly can be inserted through the insertion path 264 and into the blood vessel 200 (eg, the jugular vein), and then the catheter can be advanced through the blood vessel to the desired location ( For example, the superior vena cava for certain central venous system applications). An injection or other desired procedure can then be performed. The catheter can be removed from the patient after the procedure is complete.

  FIG. 12 illustrates one embodiment of a vascular access port 100 implanted in a patient 210 by the method as shown in FIGS. 10A-10G. A portion of the outer membrane layer 202 of the blood vessel 200 thus extends beyond the vascular access port 100. Thus, when the access device 144 is inserted into the blood vessel 200 via the access port 100, it passes through the outer membrane layer 202 before entering the vascular access port 100. On the other hand, the procedure for forming and using the buttonhole may be similar to the procedure described above with respect to FIGS.

  FIG. 13 represents an example of one embodiment of a buttonhole access site 266 in the blood vessel 200, which is formed by repeated insertion of the access device 144 through one embodiment of the vascular access port 100. FIG. FIG. 13 is a photograph of a cut-out portion of blood vessel 200 (ie, a view directed toward intimal layer 206) viewed from the bottom. The shape of the vascular access port 100 can be identified in the photograph as part of a continuous suture 116 that extends through the intimal layer 206.

  In this particular example, vascular access port 100 was implanted in a sheep body for nine weeks. After a waiting period for tissue ingrowth, a sharp needle was inserted through the vascular access port 100 to access the blood vessel 200. Six additional access events were then performed using a sharp needle followed by 12 access events using a non-pointed needle. Therefore, a total of 19 cannulations were conducted. Access events were performed three times a week.

  FIG. 14A represents an embodiment of a hemodialysis system 300 comprising two vascular access ports 100A, 100B. Both ports 100A, 100B are shown attached to a blood vessel 200 with an arteriovenous fistula 218. One port 100A is directed upstream, with its front end pointing in the opposite direction to the blood flow through blood vessel 200, and the other port 100B is directed downstream, with its front end directed to blood vessel 200. Showing the same direction as the flow of blood through it. Fistula needles can be inserted into the respective ports 100A, 100B and hemodialysis is performed. The first port 100A can be an intake port that removes blood from the blood vessel 200 and sends it to the hemodialysis machine, and the second port 100B returns the filtered blood from the hemodialysis machine back to the blood vessel 200. Can be a port.

  In other embodiments of the present invention, the hemodialysis system 300 can include a single vascular access port 100A or 100B. Hemodialysis can be performed by any suitable method (eg, a hemodialysis technique with a single needle).

  In yet another embodiment of the invention, hemodialysis system 300 includes two or more vascular access ports 100A, 100B. The clinician can therefore exchange between the plurality of ports 100A, 100B, thereby keeping one or more ports unused during a given hemodialysis period.

  FIG. 14B represents another embodiment of a hemodialysis system 350. The illustrated embodiment includes two vascular access ports 100A, 100B, although there may be more or fewer. Both ports 100A, 100B are shown attached to an artificial graft vessel 352 that serves as a shank between artery 212 and vein 214. The graft vessel 352 can include any suitable material (eg, ePTFE). The ports 100A, 100B can be attached to the graft vessel 352 before or after the graft vessel 352 is implanted. The hemodialysis system 350 can function similarly to the system 300 described above, with port 100A serving as an intake port and port 100B serving as a return port.

  15A-15G illustrate another embodiment of a vascular access port 400, which can be similar in some respects to the vascular access port 100 described above. Accordingly, similar features are indicated by the same reference numerals with the addition of “4” in the leading digit. Therefore, the following is not repeated. Accordingly, features similar to those disclosed above will not be repeated below. Furthermore, the unique features of the vascular access port 400 may not be indicated or identified by reference numerals in the figures, or may not be specifically described in the description below. However, such features may be clearly the same or substantially the same as those shown in other embodiments of the invention and / or described in connection with such embodiments. it can. Accordingly, the relevant description of this type of feature applies equally to the features of the vascular access port 400. Any combination of the same features and aspects of the vascular access port 100 can be applied to the vascular access port 400, and vice versa. This pattern of disclosure shall apply equally to the embodiments of the invention illustrated by the following figures and the following description.

  The width WF of the vascular access port 400 may be approximately equal to the width WF of the vascular access port 100, but the width WB of the vascular access port 400 may be somewhat larger than the width WB of the vascular access port 100. it can. Therefore, the wing 440 can extend beyond the outer peripheral portion 406 of the base portion 402 in a range smaller than the wing 140 of the port 100. Further, the radius of curvature of the base portion 402 can be greater than the radius of curvature of the base portion 102. The height H of the port 400 can be approximately equal to the height H of the port 100.

  Port 400 can thus be configured for use with blood vessels that are somewhat larger than port 100. However, the port 400 can be implanted in the patient at approximately the same depth as the port 100 with substantially no observable change in the patient's skin surface, and a funnel portion slightly larger than the funnel portion 132. 432 can be defined. Further, the conduit portion 434 through the port 400 can be approximately the same size and configuration (including an angle relative to the base portion 402) as the conduit portion 134. The port 400 can thus be configured for use with the same type of blood vessel as the port 100, but can be configured for different patients having larger blood vessels. For example, port 100 can be configured for vascular applications having an outer diameter of approximately 7 mm, and port 400 can be configured for vascular applications having an outer diameter of approximately 9 mm. Similar methods for implantation and use can thus be implemented for each port 100,400.

  A system for selecting a vascular access port for a given application may therefore comprise both ports 100,400. For example, a merchant can present both types of ports 100, 400 as an option to meet various customer requirements and / or supply one or both ports 100, 400 to the customer. .

  16A-16G illustrate another embodiment of a vascular access port 500, which can be similar to the vascular access ports 100, 400 described above with respect to certain features. The width WF of the vascular access port 500 may be approximately equal to the width WF of the vascular access port 400, but the width WB of the vascular access port 500 may be somewhat larger than the width WB of the vascular access port 400. it can. Therefore, the wing 540 can extend beyond the outer peripheral portion 506 of the base portion 502 in a range smaller than the wing 440 of the port 400. Further, the radius of curvature of the base portion 502 can be greater than the radius of curvature of the base portion 402. The height H of the port 500 can be approximately equal to the height H of the port 400.

  The port 500 can therefore be configured for use with blood vessels that are somewhat larger than the port 400, can be configured for use with blood vessels of the same type as the ports 100, 400, but larger vessels It can be set as the structure for using with respect to another patient who has this. For example, the port 500 can be configured for use with blood vessels having a diameter of approximately 11 mm.

  A system for selecting a vascular access port for a given application can thus comprise any combination of ports 100, 400, 500. For example, a merchant may present two or more types of ports 100, 400, 500 as options to meet various customer requirements and / or one or more ports 100, 400, 500 500 can be supplied to customers.

  17A-17G illustrate another embodiment of a vascular access port 600, which can be similar to the vascular access port described above with respect to certain features. The vascular access port 600 can include a base portion 602 that does not have an attachment passage. Thus, the port 600 can be attached to the blood vessel by several methods other than suturing (eg, with a biocompatible adhesive). However, in other embodiments of the invention, the vascular access port 600 includes an attachment passage (eg, attachment passage 114 described above).

  The port 600 may have a guide passage 630 that is different from the guide passage 130 shown in FIGS. In particular, the guide passage 630 includes a funnel portion 632 that extends from the palpation protrusion 646 to the opening 650 in the base portion 602. The passage 630 does not include a conduit portion. In some examples, the absence of the conduit portion is inserted through the passage 630, which can prevent or inhibit coupling of the access device 144. On the other hand, in some instances, the absence of a conduit portion does not limit the orientation of the access device 144 as it passes through the opening 650, which can make it difficult to form and use buttonholes in the vessel wall. is there.

  The funnel portion 632 can define various angles with respect to the base portion 602. FIG. 17G represents a cross-section along the vertical midplane of the port 600, where the front surface of the funnel portion 632 can define a maximum angle β relative to the base portion, and the rear surface of the funnel portion 632 defines a minimum angle γ relative to the base portion. be able to. The central axis AX of the guide passage 630 can pass through the center of the opening 650 along the vertical central plane and has an angle defined by (β + γ) / 2 with respect to the base.

  18A-18G illustrate another embodiment of a vascular access port 700, which can be similar to the vascular access port described above with respect to certain features. The width WF of the blood vessel access port 500 may be smaller than the width WB. Therefore, the wing 740 of the port 700 may not extend beyond the outer peripheral portion 706 of the base portion 702. In the illustrated embodiment, the outer ends of the wings 740 are substantially parallel and extend upward from the base portion 702.

  The port 700 can include a palpation projection 746 that surrounds the entire funnel portion 732 of the port. As shown, for example, in FIG. 18F, palpation protrusion 746 may be substantially flat and only a small portion may deviate from the plane defined therein. The plane defined by the palpation protrusion 746 can form an acute angle with respect to the bottom end of the base portion 702. Further, the front surface 756 of the port 700 can form an acute angle with respect to the bottom end of the base portion 702. In the illustrated embodiment, the port 700 has a conduit portion 734 that forms an acute angle with the base portion 702.

  19A-19G illustrate another embodiment of a vascular access port 800, which can be similar to the vascular access port described above with respect to certain features. Vascular access port 800 can be particularly similar to access port 700, but can be configured for implantation at a deeper location within a patient's body. For example, in some embodiments of the present invention, the base portion 802 of the port 800 and the base portion 702 of the port 700 have approximately equal widths, but the height of the port 800 can be greater than the height of the port 700. . Each port 700,800 can form approximately the same length, but the acute angle formed by the plane across the palpation projection 846 and the acute angle formed by the front surface 856 of the port 800 spans a similar palpation projection 746. It can be greater than the acute angle formed by the plane and the acute angle formed by the front surface 756 of the port 700 (compare FIGS. 18F and 19F). The angle of the conduit portion 834 relative to the base portion 802 can be greater than the angle formed by the conduit portion 734.

  The port 800 can thus be configured for use with a somewhat deeper location, but a similar sized vessel, as compared to the port 700. For example, ports 700 and 800 can each have a width of approximately 7 mm, while port 700 can have a height in the range of about 2 mm to about 3 mm, while port 800 has a height in the range of about 4 mm to about 5 mm. Can have A similar method is used to plant and use each port 700,800.

  Similarities and differences, as described above with respect to ports 700, 800, can also exist between port 900 and port 1000 shown in FIGS. 20A-20G and FIGS. 21A-21G, respectively. For example, ports 900 and 1000 can each have a width of approximately 7 mm, while port 900 can have a height ranging from about 6 mm to about 7 mm, while port 1000 can range from about 9 mm to about 10 mm. Can have a height of In the example described above, the conduit portion 734 of the port 700 can form an angle of about 20 degrees, the conduit portion 834 of the port 800 can form an angle of about 25 degrees, and the conduit portion 934 of the port 900 can be An angle of about 30 degrees can be formed, and the conduit portion 1034 of the port 1000 can form an angle of about 35 degrees. In other embodiments of the invention, the conduit portion 1034 may instead form an angle of about 30 degrees.

  A system for selecting a vascular access port for a given application can comprise any combination of ports 700, 800, 900, 1000. For example, a merchant can present two or more types of ports 700, 800, 900, 1000 as options to meet various customer requirements and / or one or more ports 700, 800, 900, 1000 can be supplied to customers.

  22A-22G show another embodiment of a vascular access port 1100 that can be similar to the vascular access port described above with respect to certain features. As shown in FIG. 22F, the port 1100 can include a palpation protrusion 1146 that is not flat (ie, it is not substantially flat).

  23A-23G illustrate another embodiment of a vascular access port 1200 that can be similar to the vascular access port described above with respect to certain features. The port 1200 can include a body portion 1204 having a top surface that bends laterally.

  The port 1200 may have a palpation protrusion 1246 that contacts the funnel portion 1232. The palpation protrusion 1246 can have a rounded end that hardly protrudes from the body portion 1204 of the port 1200. The port 1200 can further have a complementary palpation protrusion 1247, which is located at the front end of the illustrated embodiment. The palpation protrusion 1247 can have a round protrusion that extends upwardly and laterally, which can be spaced from the funnel 1232 by a recess 1249.

  The port 1200 can have a plurality of attachment passages 1214. In the illustrated embodiment, the attachment passageway 1214 extends through the bottom surface 1208 of the port 1200 within the recess 1249 and within the funnel portion 1232.

  24A-24G illustrate another embodiment of a vascular access port 1300 that can be similar to the vascular access port described above with respect to certain features. The port 1300 can be particularly similar to the port 1200, but can have an attachment passage 1314 that does not pass through the bottom surface 1308 of the port 1300. Rather, the attachment passage 1314 has a vertical post 1315 and a recess 1317 that are disposed in the body 1304 of the port 1300. Compared to port 1200, the mounting passageway 1314 can add height to the port 1300. However, the attachment passage 1314 is also disposed below and spaced from the funnel portion 1332. Such an arrangement can prevent inadvertent insertion (or attempted insertion) of the access device 144 into the blood vessel through the attachment passageway 1314.

  25A-25G illustrate another embodiment of a vascular access port 1400 that can be similar to the vascular access port described above with respect to certain features. The port 1400 can be particularly similar to the port 1200, but can have a supplemental palpation protrusion 1447 extending longitudinally at the front end. Palpation protrusions 1447 may be spaced apart from one another by recesses 1449.

  26A-26G illustrate another embodiment of a vascular access port 1500 that can be similar to the vascular access port described above with respect to certain features. The port 1500 can be similar to the port 1200 in particular, but can have a body 1504 that forms a substantially square profile when viewed from the front or rear. Further, the port 1500 can have a coupling flange 1512 that completely surrounds the body portion 1504. The coupling flange 1512 can have a plurality of mounting passages 1514 extending therethrough. The attachment passage 1514 therefore does not pass through the funnel 1532 or the recess 1549.

  FIG. 27A shows another embodiment of a vascular access port 1600, which can be similar to the vascular access port described above with respect to certain features. The port 1600 can have a base portion 1602 with a graft expansion member 1605, which can help safely attach the port 1600 to a blood vessel. In the illustrated embodiment, the graft expansion member 1605 can be fixedly attached to the remaining base portion 1602 by one or more sutures 116. Any other suitable method of attaching the graft expansion member 1605 to the base portion 1602 can be used. Graft expansion member 1605 can include any suitable material, and it may be flexible enough to allow natural variation in the range of vessel diameters. The material can also promote tissue ingrowth. In some embodiments of the present invention, the graft expansion member 1605 includes ePTFE. In the illustrated embodiment, the first side of the graft expansion member 1605 (not shown) is coupled to the port 1600 and the second side 1609 is remote from the port 1600.

  As shown in FIG. 27B, the graft expansion member 1605 is positioned around at least a portion of the blood vessel 200 and one or more attachment devices 116 are inserted through the port 1600 through the various layers of the blood vessel 200. And can be passed through the graft expansion member 1605 and secured (ie, tied in). Additional attachment devices 116 can also be used for port 1600, for example, in the manner described above.

  In some embodiments of the invention, the vascular access port 1600 can be used to repair a fistula. For example, in some embodiments of the present invention, the base portion 1602 (eg, graft expansion member 1605) can be placed around an aneurysm in the vessel wall.

  In certain embodiments of the invention, the graft expansion member 1605 can be replaced with a housing (not shown) configured to surround at least a portion of the blood vessel 200 in a manner as shown in FIG. 27B. The housing can include any suitable biocompatible material and can be sufficiently rigid to prevent the access device 144 from penetrating the side of the blood vessel opposite the port 1600.

  In various embodiments of the invention, at least a portion of the graft expansion member 1605 or housing may have a cover (not shown) (such as a covering and / or an embedded material), which may be a preservative, antibacterial Provides a substance, antibiotic, antiviral, antifungal, antiinfective, or other desirable property (eg, the ability to inhibit, reduce or stop microbial growth at or near the surface of a port) One or more materials or drugs. For example, any suitable cover material shown above can be used.

  FIG. 28 illustrates one embodiment of a vascular access system 1700. System 1700 includes an artificial graft vessel 1701 and a vascular access port 1703 attached thereto. Vascular access port 1703 can be any similar to the access ports described above. However, in some embodiments of the present invention, the bottom surface 1708 of the port 1703 may not have an ingrowth induction cover. The bottom surface 1708 can be provided with an adhesive to form a tight bond between the port 1703 and the graft vessel 1701. In some embodiments of the invention, a fluid tight seal is formed between port 1703 and graft vessel 1701, which leaks blood or other fluid between port 1703 and graft vessel 1701 during or after an access event. Can be prevented. One or more attachment devices 116 can be used to attach the port 1703 to the graft vessel 1701. The graft vessel 1701 can include any suitable material (eg, ePTFE).

  FIG. 29 shows another embodiment of a vascular access port 1800. FIG. Vascular access port 1800 includes a flexible patch 1805 that couples to its base portion 1802. The patch 1805 extends outside the outer peripheral portion of the main body 1802. Patch 1805 can include any suitable biocompatible material and can promote tissue ingrowth therein. For example, in various embodiments of the present invention, patch 1805 includes one or more of Dacron, ePTFE or polyurethane foam. The patch 1805 can be adapted to the outer surface of the blood vessel to which it is attached, and it can be attached to the blood vessel by one or more sutures, clips or other suitable devices. The patch 1805 can be configured to surround at least a portion of the blood vessel to which it is attached.

  FIG. 30 illustrates another embodiment of a vascular access port 1900. The vascular access port 1900 has a support element 1924 and a directing element 1926 that have different characteristics, for example, resistance to puncture, endurance time once implanted in a patient, or material cost. In various embodiments of the present invention, each support element 1924 and directing element 1926 can form at least part of the base portion 1902 and the body portion 1904 of one or more vascular access ports 1900. For example, in the illustrated embodiment, each support element 1924 and directing element 1926 helps form the body portion 1904, while only the support element 1924 contributes to the base portion 1902.

  In some embodiments of the present invention, the support element 1924 and the directing element 1926 are configured to maintain a predetermined shape within the patient's body, once the vascular access port 1900 has been implanted in the patient for a different period of time. Configured for. For example, in some embodiments of the present invention, support element 1924 is configured to be absorbed faster than directional element 1926 in the patient's body. For example, in various embodiments of the present invention, the support element 1924 can be at a rate no greater than about 1.5, 2, 3, 4, 5, 6, 7, 8, 9 or 10 times the rate at which the directional element 1926 is absorbed. Absorbed or support element 1924 is absorbed at a rate of about 1.5, 2, 3, 4, 5, 6, 7, 8, 9 or 10 times greater than the rate at which directional element 1926 is absorbed. In some embodiments of the present invention, the directing element 1926 can be configured to resist absorption and remain in the patient's body that is not absorbed indefinitely. In some embodiments of the invention, the directional element is fully absorbed within about 1, 2, 3, 4, 5 or 6 months, or about 1, 2, 3, 4, 5 or 6 months or more Configured as follows.

  In various embodiments of the present invention, one or both support elements 1924 and directing elements 1926 can include an absorbent material (eg, any suitable absorbent material described above). In other or further embodiments of the present invention, the directing element 1926 can include a non-absorbable material (eg, stainless steel, titanium, etc.).

  A substantial portion of the guide passage 1930 can be formed by the directional element 1926. For example, in the illustrated embodiment, the entire funnel portion 1932 and the inlet end of the conduit portion 1934 can be formed by a directional element 1926. In contrast, only the outlet end of the conduit portion 1934 is formed by the support element 1924. The more resistant it is to absorption, the longer it can withstand coring or scratching by a needle or other insertion device 144, thus also forming an insertion path through the patient's skin towards the buttonhole And can contribute to the formation of the buttonhole itself.

  As shown, the support element 1924 can surround the front end of the directing element 1926. Support element 1924 and directing element 1926 can be coupled together by any suitable method. For example, the support element 1924 and the directing element 1926 can be glued or welded together. In some embodiments of the invention, the support element 1924 can be overmolded on the directional element 1926.

  The tissue that replaces the support element 1924 supports the directing element 1926 in a similar manner so that the directing element 1926 can generally remain in the same position in the patient's body. In some embodiments of the present invention, the outer surface of the directing element 1926 (eg, the surface opposite the guide passage 1930) can include an ingrowth induction cover, such as the cover 152 described above. Thus, as the support element 1924 replaces the tissue, the tissue can reliably adhere to the directional element. Further, similar to the ports described above, at least the bottom surface 1908 of the vascular access port 1900 can include an ingrowth guidance cover 1952.

  In some embodiments of the invention, different materials can be used for the support element 1924 and the directing element 1926 as a cost-saving measure. For example, a less durable, less expensive material can be used for the support element 1924 so that there is little difference in performance in certain embodiments of the vascular access port described above. In some embodiments of the present invention, the directing element 1926 can have an inherent strength or can have a layer of coating or material that can impart strength to the support element 1924.

  FIG. 31 illustrates one embodiment of a system 2000 configured for external processing of blood. System 2000 is similar to system 300 described above. System 2000 includes two vascular access ports 100A, 100B that can be similar to any of the ports described above. Ports 100A, 100B are both shown attached to blood vessel 200 with arteriovenous fistula 218. One port 100A is directed upstream, with its front end pointing in the opposite direction to the blood flow through blood vessel 200, and the other port 100B is directed downstream, with its front end directed to blood vessel 200. Showing the same direction as the flow of blood through it. However, other arrangements are possible. A separate access device 144 (eg, a fistula needle or an over-the-needle catheter) can be plugged into the respective port 100A, 100B by any of the methods described above and by any suitable passage 2004 (eg, a tube). Connected to a processing system 2002 (eg, a hemodialysis machine).

  Blood processing can then take place. The first port 100A can be an intake port that removes blood from the blood vessel 200 and sends it to the hemodialysis machine, and the second port 100B returns the filtered blood from the hemodialysis machine back to the blood vessel 200. Can be a port. Thus, during use, blood is removed from the patient through the access device 144 in the first port 100A and sent to the blood processing system 2002. The removed blood is processed by the blood processing system 2002 in any suitable manner. The treated blood is returned to the patient through the access device 144 in the second port 100B.

  As another embodiment of the present invention, the system 2000 may comprise only a single vascular access port of 100A or 100B. The treatment of the blood can thereby be performed in any suitable way (for example a hemodialysis technique with a single needle). In yet another embodiment of the present invention, the system 2000 can include more than one vascular access port 100A, 100B. The clinician can therefore exchange between the plurality of ports 100A, 100B, thereby keeping one or more ports unused during a given blood treatment period.

  As can be seen from the above description, an embodiment of a vascular access port according to the present invention can be sized and dimensioned to be placed within the patient's body and below the patient's skin surface. For example, a vascular access port is compatible with blood vessels (eg, any suitable artery or, for example, the head, ulnar skin, femur, throat, or subclavian vein) and the epidermis of an animal subject. The size is set as follows.

  Further, one or more vascular access port embodiments can be included in various embodiments of the kit. For example, in some embodiments, the kit can include a vascular access port, such as any of the ports described above. The kit further includes one or more sutures or other attachment devices that can attach the port to the blood vessel, one or more artificial grafts (pre-attached to or away from the port), 1 1 having one or more pads of ingrowth-inducing material (pre-attached to or away from the port) and / or one or more different configurations (eg, different sizes, shapes, etc.) One or more of one or more additional vascular access ports may be provided. For example, in some embodiments of the present invention, the kit can include multiple ports, and the specialist can select one or more ports to be implanted. In further embodiments of the present invention, the kit can include different sized ports, and the specialist can select a more appropriate port based on the particular analysis and / or port target site.

  Many examples relating to the use of vascular access ports for blood vessels are presented herein, and the methods of this disclosure are used for convenience and efficiency, but are limited to the range of treatment types used in the embodiments. Note that it should not be interpreted as. Indeed, embodiments of the devices, methods and systems disclosed herein can be used for vessels other than blood vessels (eg, tubes in the gastrointestinal tract). Thus, the term “blood vessel” is a broad term and can include any hollow or walled organ or structure of living organisms, whether natural or artificial.

  It will be appreciated by those skilled in the art that changes may be made to the details of the above-described embodiments without departing from the original aspects set forth herein. For example, any suitable combination of various embodiments of the invention or features thereof is envisaged.

  Moreover, although it is bilaterally symmetric in the illustrated embodiment, some embodiments may be bilaterally asymmetric. For example, in some embodiments described above, the guide passage of the vascular access port generally extends through the port at an angle with respect to the vertical longitudinal section so that the funnel portion of the port relative to the opposite side thereof. One side can more easily accept the access device therein. Such an arrangement is useful in some applications, for example when a port is implanted on a blood vessel, and it is easier for the blood vessel to come from a different (eg non-parallel) direction to the blood vessel. It is a case to reach.

  Every method disclosed herein includes one or more steps or actions for performing the methods described above. The method steps and / or actions may be interchanged with one another. In other words, the specific steps and / or order of operations and / or methods of use can be improved unless the steps or operations need to be performed in a specific order in order to properly implement the embodiments of the present invention. .

  Throughout this application, the term “about” or “approximately”, for example, is used to express an approximation. For this type of representation, it should be understood that in some embodiments, values, features, or characteristics can be specified without using approximations. For example, in various embodiments, the height H of the vascular access port 100 is about 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 mm or less. However, in some embodiments, the height H of the vascular access port 100 is 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 mm or less. It is understood.

  With respect to “an embodiment” or “the embodiment” described throughout this specification, at least one embodiment includes a particular feature, structure, or characteristic that is indicated with respect to that embodiment. Means. Thus, all quotes or variations thereof described throughout the specification are not necessarily all referring to the same embodiment.

  Similarly, in the above description of the embodiments, various features are sometimes combined in one embodiment, figure, or description thereof to streamline the disclosure. This method of disclosure, however, should be construed as reflecting the intention that the claimed invention requires additional features beyond the scope of the features explicitly recited in each claim. is not. Rather, as the following claims reflect, aspects of the invention are expressed as a combination of fewer than all the features in any one of the above disclosed embodiments. Thus, the claims following this detailed description are hereby expressly incorporated into this detailed description, with each claim standing on its own as a separate embodiment. This disclosure includes all substitutions of independent claims with dependent claims.

  In the claims, the term “first” for a feature or element does not necessarily indicate the presence of a second or additional such feature or element. Aspects of the invention claiming exclusive ownership or rights are set forth below.

Claims (23)

A vascular access port implanted subcutaneously, the vascular access port comprising:
A base portion extending in a longitudinal direction and a lateral direction, the base portion is curved in the lateral direction, and conforms to a shape of a blood vessel wall when the blood vessel access port is attached to a blood vessel, and the vertical direction of the base portion is Substantially parallel to the lumen of the blood vessel when attaching the blood vessel access port to the blood vessel;
A guide passage extending through the vascular access port and defining an opening in the base portion, wherein a central axis extending through the guide passage forms an acute angle with respect to a longitudinal length of the base portion; The acute angle points forward with respect to the front end of the vascular access port,
An ingrowth-inducing cover on the base, at least a portion of the ingrowth-inducing cover is located between the opening of the guiding passage and the front end of the vascular access port; A blood vessel access port that promotes adhesion of the blood vessel access port to the blood vessel and holds the opening of the guide passage in a predetermined position with respect to the blood vessel wall. The vascular access port of claim 1.
A vascular access port, wherein the ingrowth guide cover surrounds the opening of the guide passage.   The vascular access port of claim 1, further comprising a flange that at least partially surrounds the opening of the guide passage, the flange having one or more attachment passages, and the one or more attachment members therein. A vascular access port extending through and attaching the vascular access port to a blood vessel.   4. A vascular access port according to claim 3, wherein the flange has a mounting passage at the front end of the vascular access port.   4. The vascular access port of claim 3, wherein the flange has a plurality of attachment passages extending through a base portion, the attachment passages defining an outer periphery of an attachment region covered by the ingrowth guidance cover. , Vascular access port.   6. The vascular access port according to claim 5, wherein an opening of the guide passage is in the attachment region.   2. The vascular access port according to claim 1, wherein the ingrowth-inducing cover is limited to a bottom surface of a base portion of the vascular access port, the upper portion of the vascular access port is smooth, and fascia ingrowth is performed on the upper portion of the vascular access port. Prevent the vascular access port.   The vascular access port of claim 1, wherein the ingrowth-inducing cover comprises a plurality of titanium beads having an average diameter of about 5/1000 inch or less.   The vascular access port according to claim 1, wherein the height of the vascular access port is about 0.5 times or more the width of the base portion.   The vascular access port according to claim 1, wherein the guide passage does not comprise a closure device.   The vascular access port according to claim 1, wherein the acute angle between a central axis of the guide passage and a longitudinal length of the base portion is about 60 degrees or less.   The vascular access port of claim 1, further comprising a graft expansion member, housing, or patch that surrounds at least a portion of a blood vessel and secures the vascular access port to the blood vessel.   The vascular access port of claim 1, wherein a portion of the vascular access port attached to a blood vessel comprises a first absorbent material.   14. A vascular access port according to claim 13, wherein the guide passage comprises a non-absorbable material or a second absorbent material having a slower absorption rate than the first absorbent material. In the vascular access port
A base portion extending in a longitudinal direction and a lateral direction, the base portion is curved in the lateral direction, and conforms to a shape of a blood vessel wall when the blood vessel access port is attached to a blood vessel, and the vertical direction of the base portion is Substantially parallel to the lumen of the blood vessel when attaching the blood vessel access port to the blood vessel;
A guide passage extending through the vascular access port, wherein a central axis defined by the guide passage forms an acute angle with respect to a longitudinal length of the base portion, the acute angle being relative to the front end of the vascular access port Facing forward,
An attachment passage provided in front of the guide passage, the attachment device extending through the attachment passage, allowing the vascular access port to be coupled to a blood vessel, the access device facing the guide passage; or A vascular access port that inhibits forward movement of the vascular access port relative to the blood vessel as it advances through the guide passage.   The vascular access port according to claim 14, wherein the attachment device comprises any one of a suture, a pinch ring, a hook, and a wire.   15. A vascular access port according to claim 14, wherein the guide passage defines an opening in the bottom surface of the base portion.   15. A vascular access port according to claim 14, wherein the guide passage has a funnel portion that decreases in size toward the conduit portion, the funnel portion being located behind the conduit portion. .   The vascular access port of claim 14, further comprising an additional attachment passage at a rear end of the vascular access port.   15. A kit with a vascular access port according to claim 14, comprising one or more sutures, an artificial graft, and one or more additional vascular access ports. A method of implanting a vascular access port, the method comprising:
A vascular access port through which a guide passage extends, wherein a proximal opening of the guide passage is larger than a distal opening and guides an access device inserted into the guide passage toward the distal opening Providing a vascular access port comprising the guide passage;
Make an incision in the patient's skin to expose the blood vessels,
With the distal opening facing the blood vessel, the blood vessel access port is fixedly attached to the blood vessel,
Closing the incision and positioning the vascular access port completely below the skin surface. The method of claim 21, wherein
Fixed attachment of the vascular access port to a blood vessel includes defining the orientation of the guide passage such that its central axis forms an acute angle with the lumen of the blood vessel. The method of claim 21, wherein
Fixed attachment of the vascular access port to a blood vessel
Securing an attachment device to both the vascular access port and the blood vessel at a location in front of the distal opening of the guide passage.

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